Multi-Institutional Validation of the Predictive Power of the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) for HCT Outcomes

Multi-Institutional Validation of the Predictive Power of the Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) for HCT Outcomes
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造血细胞移植合并症指数 (HCT-CI) 对 HCT 结果的预测能力的多机构验证

DOI:
10.1182/blood.v118.21.145.145
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发表时间:
2011
期刊:
影响因子:
20.3
通讯作者:
B. Storer
B. Storer
中科院分区:
医学1区
文献类型:
--
作者:
M. Sorror;F. Ostronoff;R. Storb;S. Bhatia;R. Maziarz;M. Pulsipher;M. Maris;H. Deeg;P. Martin;F. Appelbaum;D. Maloney;B. Sandmaier;B. Storer

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摘要145 2005年,HCT-CI被引入作为预测异基因HCT后死亡风险的加权评分系统。从那时起,并不是所有的调查人员在各自的机构进行测试后都能够验证HCT-CI。2007年,启动了一项合作的多机构研究,以调查1)HCT-CI是否可以预测不同机构的结果,2)结果预测的同质性程度,以及3)调查人员之间缺乏一致的原因。为此,我们收集了2000年至2006年间连续接受异基因HCT治疗的3347名患者的数据,这些患者来自5个机构的HLA配型匹配的亲属或非亲属捐赠者。所有数据都由一名研究人员收集,从PTS的最终结果中保密,以确保一致的共病编码。不同机构的PTS数量、可用共病数据的百分比以及移植和PT的其他特征在统计学上有显著差异(表1)。缺失共病或其他协变量数据的PTS被排除在进一步分析之外,最终样本量为2523。总体而言,Hct-CI评分为0、1-2和≥3的患者的2年无复发死亡率分别为14%、23%和39%(p=0.03)和≥3(p=0.04),OS评分为≥3(p=0.01),但OS评分为1-2(p=0.18)。我们还发现机构对NRM(p=0.001)和OS(P)有统计学上显著的独立影响(p然后我们评估了来自机构A的80名患者中,两个单独的研究人员之间以及他们各自与来自其他评估者池中的未知个体之间的评分共病的观察者间的变异性。加权kappa统计量在两个单一评估者之间最高(0.59),在每个评估者和多个评估者之间最低(分别为0.43和0.55)。然后,首席调查员制定了一份全面的指南,对合并症进行编码,并在一次会议上对另一名调查员进行了培训。对观察员间协议的进一步评价表明,加权kappa统计量有了显著改善,达到0.78。所报道的关于HCT-CI有效性的分歧可能是由于管理移植患者的不同机构经验、一些机构的少量患者以及观察者之间在评分分配上的差异。HCT-CI对于区分不同机构间HCT后死亡的相对风险是有效的,应定期用于咨询患者和临床试验设计。改进共病编码方法的工作正在进行中。披露:没有相关的利益冲突需要申报。
Abstract 145 In 2005, the HCT-CI was introduced as a weighted scoring system to predict mortality risk following allogeneic HCT. Since then, not all investigators were able to validate the HCT-CI after testing in their respective institutions. In 2007, a collaborative multi-institutional study was initiated to investigate 1) whether the HCT-CI was predictive of outcomes across different institutions, 2) the degree of homogeneity of outcome prediction, and 3) the reasons for lack of agreement among investigators. To this end, data were collected from 3347 consecutive patients (pts) treated with allogeneic HCT between 2000 and 2006 from HLA-matched related or unrelated donors at 5 institutions. All data were collected by a single investigator, blinded from the final outcomes of pts, to ensure consistent comorbidity coding. Numbers of pts, percentages of available comorbidity data, and other transplant and pt characteristics were statistically significantly different among institutions (Table 1). Pts missing comorbidity or other covariate data were excluded from further analyses, yielding a final sample size of 2523. Overall, pts with HCT-CI scores of 0 vs. 1–2 vs. ≥3 had 2-year non-relapse mortality (NRM) rates of 14%, 23%, and 39% ( p p p =0.03) and ≥3 ( p =0.04) for NRM and with scores ≥3 ( p =0.01) for OS but not with scores 1–2 for OS ( p =0.18). We also found a statistically significant, independent impact of institution on NRM (p=0.001) and OS (p We then assessed, among 80 pts from institution A, the inter-observer variability in scoring comorbidity between two individual investigators and between each of them and unknown individuals from a pool of other evaluators. Weighted kappa statistics were highest (0.59) between two single evaluators and lowest between each and multiple evaluators (0.43 and 0.55, respectively). The principal investigator then developed a comprehensive guideline to code comorbidities and used it to train the other single investigator in a single session. Additional evaluation of inter-observer agreement demonstrated marked improvement of the weighted kappa statistic to 0.78. The reported disagreements on the validity of the HCT-CI may be explained by different institutional experiences in managing transplant pts, small number of pts at some institutions, and inter-observer variability in score assignment. The HCT-CI is valid to discriminate relative risks of mortalities after HCT across different institutions and should be used regularly for counseling pts and clinical trial design. Efforts to improve methods for coding comorbidity are in progress. Disclosures: No relevant conflicts of interest to declare.